Quality and Regulatory Specialist
About The Position
Rose Medical is a fast-growing medical device manufacturer dedicated to producing high-quality, innovative products that make a difference in people’s lives. We are seeking a Quality and Regulatory Specialist to manage and continually improve our Quality Management System while ensuring compliance with ISO 13485 and FDA regulations. This is a hands-on, detail-driven position that plays a vital role in maintaining Rose Medical’s reputation for quality and integrity. You’ll work across teams to ensure processes meet regulatory standards, audits run smoothly, and new requirements are implemented effectively.
Requirements
- Bachelor of Science degree or equivalent combination of education and experience.
- 5+ years of experience in a Quality Systems role, preferably in medical device manufacturing.
- Strong working knowledge of ISO 13485 and FDA QSRs.
- Experience with CAPA, supplier controls, audits, validation, and risk management.
- Solid understanding of basic statistical and engineering principles.
- Ability to thrive in a fast-paced environment and manage multiple priorities effectively.
- Excellent communication and collaboration skills; positive, team-oriented mindset.
Nice To Haves
- Familiarity with Product Data Management systems preferred.
Responsibilities
- Manage third-party audits (ISO 13485, customer, and FDA inspections).
- Lead and execute the CAPA process, ensuring timely and effective resolution of issues.
- Maintain and manage the Approved Supplier List and supplier controls.
- Coordinate and execute internal audits and QSP training programs.
- Keep presentations and documentation current while conducting training sessions.
- Coordinate and manage equipment calibrations and environmental condition reviews.
- Stay current with ISO and FDA GMP standards, implementing new requirements as needed.
- Provide measurement and analysis data for management review and quality objectives.
- Assist with contractual documentation (quality agreements, NDAs, etc.) and document control.
- Support the engineering team with process validation and risk management activities.
- Investigate nonconformances, coordinate corrective actions, and follow through to prevent recurrence.
- Complete customer surveys and other compliance documentation as required.
Benefits
- Competitive compensation – Salary based on experience and qualifications
- Quarterly bonus program
- Paid time off and holidays
- Medical (with diabetic supplies covered at 100%)
- Dental (includes orthodontics for kids and adults)
- Vision
- 401(k) with 4% company match
- Disability and life insurance options
- Tuition reimbursement program
- Childcare discount program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
